Manager, Quality Control
Lyell Immunopharma
5 hours ago
On-site
Bothell, WA
Operations
Manager, Quality Control – Cell Therapy (Onsite)
Role Responsibilities:
- Lead day-to-day QC lab operations supporting release and in-process testing of cell therapy products.
- Oversee analytical testing: flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
- Manage the Contamination Control Program for the manufacturing site.
- Ensure timely testing and release of raw materials and drug product.
- Support method transfer, qualification, validation, and lifecycle management of analytical methods.
- Manage, mentor, and develop QC analysts and supervisors; establish staffing and training plans.
- Review/approve analytical records, certificates of analysis, and lab documentation.
- Ensure lab equipment maintenance/qualification (BMRAM experience a plus).
- Oversee stability testing programs.
- Partner cross-functionally (Manufacturing, QA, Regulatory, Analytical Development, MST, Supply Chain) for product release and continuous improvement.
- Initiate/lead deviations, Change Controls, and CAPAs (MasterControl a plus).
- Support regulatory filings, inspections, and client audits.
Qualifications:
- BSc (10+ years in relevant field) or MSc (7+ years).
- 10+ years in cGMP biopharmaceutical manufacturing with 5+ years in cell therapy.
- Strong technical knowledge of cell therapy release testing assays.
- 5+ years managing people in technical GMP roles.
Skills/Abilities:
- 8+ years in GMP-regulated industry; prior cell therapy environment experience is required.
- Leadership, analytical/problem-solving skills.
- Experience with LIMS/ELN/electronic batch records; method validation and regulatory submissions.
- Familiarity with FDA ATMP expectations.
- Occasional weekend/holiday coverage required.
Preferred/Other:
- Onsite role; no remote work option.
Benefits/Compensation:
- Salary range: $124,000–150,000 annually; annual bonus opportunity; eligible for Lyell Equity Incentive Plan.
Role Responsibilities:
- Lead day-to-day QC lab operations supporting release and in-process testing of cell therapy products.
- Oversee analytical testing: flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
- Manage the Contamination Control Program for the manufacturing site.
- Ensure timely testing and release of raw materials and drug product.
- Support method transfer, qualification, validation, and lifecycle management of analytical methods.
- Manage, mentor, and develop QC analysts and supervisors; establish staffing and training plans.
- Review/approve analytical records, certificates of analysis, and lab documentation.
- Ensure lab equipment maintenance/qualification (BMRAM experience a plus).
- Oversee stability testing programs.
- Partner cross-functionally (Manufacturing, QA, Regulatory, Analytical Development, MST, Supply Chain) for product release and continuous improvement.
- Initiate/lead deviations, Change Controls, and CAPAs (MasterControl a plus).
- Support regulatory filings, inspections, and client audits.
Qualifications:
- BSc (10+ years in relevant field) or MSc (7+ years).
- 10+ years in cGMP biopharmaceutical manufacturing with 5+ years in cell therapy.
- Strong technical knowledge of cell therapy release testing assays.
- 5+ years managing people in technical GMP roles.
Skills/Abilities:
- 8+ years in GMP-regulated industry; prior cell therapy environment experience is required.
- Leadership, analytical/problem-solving skills.
- Experience with LIMS/ELN/electronic batch records; method validation and regulatory submissions.
- Familiarity with FDA ATMP expectations.
- Occasional weekend/holiday coverage required.
Preferred/Other:
- Onsite role; no remote work option.
Benefits/Compensation:
- Salary range: $124,000–150,000 annually; annual bonus opportunity; eligible for Lyell Equity Incentive Plan.